# K161860: TG-970P CO2 Sensor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Feb 24, 2017 after 233 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915494 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122214: TG-970P Sensor Kit W/ New Airway Adapter (YG-213T), Nihon Kohden Corp. (2013) Summary page 4.

## Indications for use
The Nihon Kohden TG-970P CO2 sensor kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status. Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital or clinical environment.

Source page: https://510kreport.com/device/K161860
Methodology: https://510kreport.com/methodology